Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The objective of this study is to evaluate the feasibility and effectiveness of
immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline,
Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia
(SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR)
+ partial response (PR)) at day 180 after the start of IST. Secondary endpoints include
evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and
EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and
CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse
rate and overall survival.